Transcript Slide 1

Pharmacy in Public Health:
Law in Public Health
Course, date, etc. info
Introduction
• Public health differs from pharmacy practice
in that it can enforce behaviors via law
• Public health laws address a variety of issues
related to determinants of health and health
risks
• Inspirations for many pharmacy laws can be
traced back to a public health issue
Learning Outcomes
• Describe the source of authority for federal
and state governments to pass public health
laws
• Describe public health problems that inspired
the passage of pharmacy laws
• Explain how international approaches to
public health issues can be addressed
• List and describe ongoing or emerging public
health issues that may inspire future laws or
regulations
Source of Authority
• States have “police power”
• State government has power to act on behalf of
its citizens to protect or benefit them
• Unless that power is explicitly given to the federal government
• State authority reiterated in the 10th Amendment
• Police power may be delegated to local
governments
• Police power gives states the ability to create
and enforce laws that restrict or mandate
behaviors
• This leads to a constant effort to ensure laws
are not unduly restrictive of individual freedom
Areas of Public Health Law
• Change behavior
• Modifying high-risk behaviors
• Requiring behaviors
• Prohibiting behaviors
• Regulate products or services
• Licensure
• Manufacturing
• Distribution and advertising
• Protect vulnerable populations or places
• Access to services including healthcare
• Clean and safe environment
• Human rights protection
Examples of Historically Important Public Health Laws
and Court Decisions
Year Act
1905 Jacobson v. Massachusetts
Purpose
1935 Social Security Act
First federal law to address social welfare
through retirement benefits and health insurance
1938 Federal Food, Drug, and
Cosmetic Act
1946 Hill-Burton Act
Required proof of safety prior to marketing
medicines
1964 New York Mental Hygiene
Law
1964 Civil Rights Act (Title VI)
1969 National Environmental
Policy Act
U.S. Supreme Court upheld mandatory
vaccinations as an acceptable use of state police
power
Promote improvements and expansions of
healthcare infrastructure
State law that abolished mandatory
hospitalization by judicial decision and replaced it
with medical decision.
Designed to address issues created by
discrimination
Required environmental impact studies prior to
initiating new programs
Table 4.1, pg 78
Faulty Products
• There are many ways a product can cause
harm:
• Fails to work (ineffective, sub-therapeutic, false claims)
• Causes harm (unsafe ingredients, tampered)
• Intentionally altered (counterfeit, adulterated)
Example: Fraudulent Products
1905-06 Expose’ on Quack Medicines
• Situation:
• No legal requirement to list any
ingredients on label
• Post- civil war era explosion in
use of patent medicines
Problem:
• Fraudulent products marketed
• Deaths and disability with no
accountability
• Resolution:
• 1906 Food and Drug Act
Example: Unsafe ingredients
1937 Elixir Sulfanilamide tragedy
• Situation:
• No legal requirement to list inactive
ingredients on label
• Needed a liquid form of new sulfa
antibiotic for children
• Problem:
• DEG used as diluent – it is toxic.
• Over 100 people, mostly children die
• Resolution:
• Federal Food, Drug &Cosmetics Act of
1938
Photo source U.S. FDA, Center for Drug Evaluation and Research
Example: No Efficacy Standards
1950s European Thalidomide Tragedy
• Situation:
• Product approved in Europe; under review in U.S.
– Approval delayed because of neurological studies results
• Voluntary standards for new products
• Problem:
• Teratogenic effects appear in Europe
• Need more stringent requirements
for new product approval
• Resolution:
• 1962 Kefauver-Harris Drug Amendment
Example: Product Tampering
1980s Cyanide-laced Tylenol Capsules
• Situation:
• Extra-strength Tylenol capsules could be opened
• No seals or tamper-evident packaging
• Problem:
• Person opened capsules, added cyanide, replaced
products on store shelves
• Seven people were poisoned and died
• Resolution:
• 1982 Tamper-resistant packaging regulations
• Manufacturer switched to a caplet dosage form
Some of the Federal Pharmacy Laws
Inspired by Faulty or Dangerous Medications
Year Act
Purpose
1906 Food and Drugs Act
(1912) (Sherley Amendment)
To eliminate the sale of adulterated products and
making false claims of therapeutic effectiveness.
Intent to defraud must be proven.
1938
Federal Food, Drug,
Has many purposes, including a requirement for new
and Cosmetic (FDC) Act drugs to be proven safe prior to marketing and
of 1938
eliminates need to prove intent to defraud
consumers
1962
Kefauver-Harris Drug
Amendment
New drug products must be proven both safe and
efficacious prior to marketing
1972
Over-the-Counter Drug
Review
Non-prescription medications must be safe, effective,
and appropriately labeled.
1982
Tamper-resistant
Packaging Regulations
Makes it a crime to tamper with packaged products
and requires tamper-proof packaging
Table 4.2, pg 83
Evolution of the Medicine Bottle and Label
Figure 4.5, pg 81
Mutual Recognition Agreements
• Issue: medication made in other countries for
sale to the U.S. may not be of the same quality
• Some may have higher standards; some lower
• International agreements (contracts not laws)
used to set minimum standards for a product
– Between governments or agencies
– Equivalence of processes or products must be
shown
– FDA is moving toward MRAs
Distribution Regulations
• Issue: once a product leaves the manufacturer,
it may be altered or tampered with before it
reaches the pharmacy
• Primary wholesalers (authorized distributors)
• Buy directly from manufacturer
• Secondary wholesalers (unauthorized)
• Do not receive product directly from manufacturer
• May re-distribute products from end-users
• Often the point where bogus products enter the market
• Pedigrees - track products from manufacturer
to purchaser
Unsafe Use
• Unsupervised use of potent medications
• Medication errors
• Abuse of clinically used medications
Issue: Access to medications
• Issue: Uninsured or underinsured populations
and healthcare costs that will bankrupt most
people if not insured for catastrophic event
• Out-of-pocket expense
• Rapid rise in cost often outstrips the financial resources
of a retired or minimum wage worker
• Creation of Medicare and Medicaid
Federal Pharmacy Laws Inspired by Unsafe Use
and Access Issues
Year Act
Purpose
1914
Harrison Narcotic Act
Requires prescriptions for products with higher
levels of narcotics and increases recordkeeping
requirements
1951
Durham-Humphrey
Amendment
Restricts the sale of medications that require
medical supervision to prescription status (VERIFY)
1970
Comprehensive Drug Abuse
Prevention and Control Act
Categorizes drugs on basis of abuse and addiction
risk compared to therapeutic benefit
1988
Prescription Drug
Marketing Act
Designed to eliminate diversion of products from
legitimate channels of distribution and requires
wholesalers to be licensed
1997
Food and Drug
Administration Modernization
Act
Medicare Prescription Drug
Improvement and
Modernization Act of 2003
Expands scope of agency activities and moves
agency to the DHHS
2003
Includes Medicare Part D which increases access
to medications through private insurers
Table 4.3, pg 85
Issue: Inappropriate disposal
practices
• Issue: unregulated disposal of industrial,
healthcare, and home medical wastes
• Contamination of water, soil, and air is a
health hazard to humans and animals
• 1976 Resource Conservation Recovery Act
(RCRA)
• Non-hazardous wastes
– Biological or medical wastes
• Hazardous wastes
– Ignitable, corrosive, reactive, or toxic
Examples of state-level laws
• Practice Acts
• Define scope of practice for professionals
• Prescriptive authority
• Dispensing versus administration
• Professional Boards
• Professional licensure
• Practice site licensure
• Respond to complaints
• Public health insurance programs
• Medical waste disposal
Issue: (Re-)Emerging Issues
• Growth of law and regulation
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Product safety
Product effectiveness
Safe use of products
Access to safe products and care
Proper disposal
Issue: (Re-)Emerging Issues
• Same issues persist today- often in new ways
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Global influences and travel
Technological advances
Internet and information sharing
Human nature (both the good and the bad)
Summary
• Police power allows state and local
governments to pass laws that support public
health efforts
• Most pharmacy laws have their origins as a
response to a public health issue
• Old problems are re-emerging with the advent
of technology, global trade, and will require
new or amended laws to address them